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Continuous enteral feeding is the most common type of nutrition used in critically ill patients despite being non-physiologic, as all mammalian alimentary tracts have been designed for intermittent ingestion of nutrients. The small numbers of randomized controlled studies that have compared intermittent gastric feeds (IGF) to continuous gastric feeds (CGF) in intensive care units have demonstrated that IGF is safe, feasible and have the shorter time to goal nutrition. Studies of healthy adults have also demonstrated that the mean glucose concentration (MGC) is lowered when bolus enteral feedings are used instead of continuous feeds; these changes in glucose-insulin metrics might be beneficial to a critically ill patient population where stress hyperglycemia is common. This study will compare the effects of CGF and IGF in a critically ill medical patient population. Glucose-insulin dynamics for each type of enteral feed will be analyzed by performing a randomized crossover study to compare the effects of CGF and IGF on MGC, total insulin infused, glucose variability (GV), episodes of hypoglycemia and maximum glucose concentration values.
This will be a non-blinded randomized crossover study in a generalized population of critically ill adults. The population of this study is defined from the ages of 18-90 admitted to the Medical Intensive Care Unit (MICU). This study will compare the glucose-insulin dynamics in critically ill adults that are feed using either a CGF or IGF scheme while their glucose concentrations are maintained between 140-180 mg/dl using an insulin infusion protocol. Randomization performed using computer generated random numbers kept individually in sealed envelopes. All participants will have nasal gastric or oral gastric (NG/OG) tube previously placed for their nutritional needs. The amount of Osmolite given will be determined by the ideal weight for each participant: 1.2 cal/ml Osmolite with caloric goal of 25 kcal/kg/day. Feeding intolerance develops which is defined as: excessive abdominal distention, emesis, abdominal pain, vomiting and gastric residual > 250 ml for IGF and gastric residual > 500 ml for CGF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Enteral Feeding | Other | Crossover Study: Randomized to continuous enteral feeding first then crossed over to receive versus intermittent enteral feeding next. |
|
| intermittent enteral feeding | Other | Crossover Study: Randomized to intermittent enteral feeding first then crossed over to receive versus continuous enteral feeding next. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total insulin infused | Total insulin infused | total time in the protocol should be 36 hours to include crossover |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose concentration | Mean glucose concentration | time the protocol should be 36 hours to include crossover |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose standard deviation | Glucose standard deviation | total time in the protocol should be 36 hours to include crossover |
| Maximum glucose concentration | Maximum glucose concentration |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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|
| Osmolite 1.2 cal/ml Enteral Feeds | Dietary Supplement | Osmolite 1.2 cal/ml Enteral Feeds via feeding tube (oral- or naso-gastric tube) |
|
| total time in the protocol should be 36 hours to include crossover |
| Minimum glucose concentration | Minimum glucose concentration | total time in the protocol should be 36 hours to include crossover |
| Episodes of hypoglycemia | Glucose concentration < 70 mg/dl | total time in the protocol should be 36 hours to include crossover |
2. Chowdhury, Abeed H., et al. "Effects of Bolus and Continuous Nasogastric Feeding on Gastric Emptying, Small Bowel Water Content, Superior Mesenteric Artery Blood Flow, and Plasma Hormone Concentrations in Healthy Adults: A Randomized Crossover Study." Annals of Surgery (2014). |
| ID | Term |
|---|---|
| C080652 | Osmolite |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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